Method and apparatus for penetrating tissue

Abstract

A body fluid sampling system for use on a tissue site has a housing and a penetrating member driver at least partially within the housing. At least one cartridge is in the housing. The cartridge includes an analyte sensor in a sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member. A penetrating member is associated with the sample chamber. Each penetrating member, and its associated sample chamber, has a combined occupied volume of no more than about 5.0 cm3. The penetrating member is at least partially co-located with the analyte sensor in the sample chamber. The sample chamber receives body fluid from a wound in tissue created by a penetrating member, and the analyte sensor determines analyte levels using a body fluid sample of less than about 1 microliter. A transport mechanism engages the cartridge. The penetrating member is operatively engaged with the penetrating member driver when moved into position by the transport mechanism. The driver provides the force to advance the penetrating member. A user interface on the housing displays information to a user.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a divisional of US Ser. No. 335,052, filed Dec. 31, 2002, which is a continuation-in-part of U.S. Scr. No. 10 / 127,395 filed Apr. 19, 2002. This application also claims the benefit of priority from commonly assigned, copending U.S. patent application Ser. No. 10 / 237,261, filed Sep. 5, 2002 and U.S. patent application Ser. No. 10 / 237,262 filed Sep. 5, 2002. All applications listed above are fully incorporated herein by reference for all purposes.BACKGROUND OF THE INVENTION [0002] Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis. Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin. [0003] Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancin...

AI Technical Summary

Benefits of technology

[0006] Accordingly, an object of the present invention is to provide improved tissue penetrating systems, and their methods of use.

[0007] Another object of the present invention is to provide tissue penetrating systems, and their methods of use, that provide reduced pain when penetrating a target tissue.

[0014] A further object of the present invention is to provide improved tissue penetrating systems, and their methods of use, that have user interfaces.

[0015] Another object of the present invention is to provide improved tissue penetrating systems, and their methods of use, that have human interfaces.

Problems solved by technology

Unfortunately, the pain associated with each lancing event using known technology discourages patients from testing.

In addition to vibratory stimulation of the skin as the driver impacts the end of a launcher stop, known spring based devices have the possibility of harmonically oscillating against the patient tissue, causing multiple strikes due to recoil.

This recoil and multiple strikes of the lancet against the patient is one major impediment to patient compliance with a structured glucose monitoring regime.

Another impediment to patient compliance is the lack of spontaneous blood flow generated by known lancing technology.

In addition to the pain as discussed above, a patient may need more than one lancing event to obtain a blood sample since spontaneous blood generation is unreliable using known lancing technology.

Known devices poorly account for these skin thickness variations.

A still further impediment to improved compliance with glucose monitoring are the many steps and hassle associated with each lancing event.

The large number of steps required in traditional methods of glucose testing, ranging from lancing, to milking of blood, applying blood to the test strip, and getting the measurements from the test strip, discourages many diabetic patients from testing their blood glucose levels as often as recommended.

Older patients and those with deteriorating motor skills encounter difficulty loading lancets into launcher devices, transferring blood onto a test strip, or inserting thin test strips into slots on glucose measurement meters.

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